To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia

JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.

Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperlipemia
• Intervention / Treatment: Drug: JS002

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anzhen Hospital Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent.
2. Age ≥12 and ≤75 years old;
3. Weight ≥40kg at the time of screening
4. Patients diagnosed with HoFH
5. Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria:

1. History of NYHA class III-IV heart failure or EF<30%
2. History of uncontrolled arrhythmia within 3 months
3. History of MI,UA, PCI or CABG, stroke within 3 months.
4. History of DVT or pulmonary embolism within 3 months.
5. Planned cardiac surgery or revascularization.
6. Uncontrolled hypertension.
7. Uncontrolled diabetes mellitius (HbA1c>8.0%）.
8. Other conditions that the researchers considered inappropriate to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.	Drug: JS002; Biological: JS002 Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint of effectiveness	Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Anticipated): May 6, 2022
• Study Completion (Anticipated): July 29, 2022

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: JS002-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No